NDC 75398-580

H2One Advanced Formula Hand Sanitizer

Ethyl-alcohol

H2One Advanced Formula Hand Sanitizer is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Samarian Products, Llc. The primary component is Alcohol.

• Product ID: 75398-580_a4450ca3-322e-28ae-e053-2995a90a9a43
• NDC: 75398-580
• Product Type: Human Otc Drug
• Proprietary Name: H2One Advanced Formula Hand Sanitizer
• Generic Name: Ethyl-alcohol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-04-27
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part333A
• Labeler Name: Samarian Products, LLC
• Substance Name: ALCOHOL
• Active Ingredient Strength: 75 mL/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 75398-580-25

250 mL in 1 BOTTLE (75398-580-25)

• Marketing Start Date: 2020-04-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75398-580-50 [75398058050]

H2One Advanced Formula Hand Sanitizer GEL

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-27

NDC 75398-580-25 [75398058025]

H2One Advanced Formula Hand Sanitizer GEL

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-27

NDC 75398-580-37 [75398058037]

H2One Advanced Formula Hand Sanitizer GEL

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-27

Drug Details

Active Ingredients

Ingredient	Strength
ALCOHOL	75 mL/100mL

OpenFDA Data

• SPL SET ID: a4450865-16b5-9b41-e053-2995a90a75e1
• Manufacturer:
  • Samarian Products, LLC
• UNII:
  • 3K9958V90M
• UPC Code:
  • 0375398000049

NDC Crossover Matching brand name "H2One Advanced Formula Hand Sanitizer" or generic name "Ethyl-alcohol"

NDC	Brand Name	Generic Name
75398-580	H2One Advanced Formula Hand Sanitizer	ETHYL-ALCOHOL
75398-275	H2One Hand Sanitizer	ETHYL-ALCOHOL
75398-880	Shaboink Alcohol Wipe	ETHYL-ALCOHOL